Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery: a Double-blind, Randomised Controlled Trial Using the Non Invasive Cardiac Output Monitor StarlingTM SV.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in maternal cardiac output (CO)
研究概览
简要总结
Spinal anaesthesia is the anaesthetic technique of choice for elective caesarean delivery. Hypotension, a result of the decrease in systemic vascular resistance caused by spinal anaesthesia, is a frequent complication occurring in up to 80%. This study is to investigate fluid loading plus vasopressors to vasopressors alone to maintain stable maternal haemodynamics in elective caesarean delivery. The effect of the two methods (continuous prophylactic phenylephrine infusion with and without crystalloid co-loading) on maternal haemodynamics will be compared using the Starling SV Monitor. The Starling SV device is a non invasive cardiac output monitor (NICOM) which is certified and validated for the use in pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigator and participant cannot see to which study group the participant belongs. The person performing randomisation and fluid application will not be involved in the data collection and Analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent
- •Term uncomplicated singleton pregnancy
- •Undergoing elective caesarean section under spinal anaesthesia
- •Weight: 50-100kg
- •Height: 150-180cm
- •Healthy term fetus
排除标准
- •Inability to give informed consent
- •Multiple pregnancy
- •Clinically significant concomitant disease states (e.g. hypertension, cardiac disease, severe asthma requiring regular medication, comorbidities affecting the autonomous nervous system, renal disease)
- •On any cardiovascular medication
- •Complications of pregnancy (e.g. preeclampsia, intrauterine growth restriction, fetal malformations)
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Any fetal pathology (e.g. fetal malformations, rupture of membranes before caesarean section, oligohydramnios, polyhydramnios, suspected chorioamnionitis)
研究组 & 干预措施
Phenylephrine infusion only
Phenylephrine infusion only
干预措施: Phenylephrine infusion (Drug)
Phenylephrine infusion and Ringer-Acetate bolus
Phenylephrine infusion and Ringer-Acetate bolus
干预措施: Phenylephrine infusion and Ringer-Acetate bolus (Drug)
结局指标
主要结局
Change in maternal cardiac output (CO)
时间窗: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
CO measured by area under the curve (AUC) (L/min.)
次要结局
- Change in maternal diastolic and systolic blood pressure(measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping)
- incidence of maternal nausea(measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping)
- Change in umbilical cord pH(at 1 and 5 minutes after delivery)
- Change in maternal heart rate(measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping)
- Change in Apgar scores(at 1 and 5 minutes after delivery)